Dr. Catalona’s patients and research participants in his studies continue to ask about the status of the litigation in the dispute between Washington University in St. Louis (WU) and Dr. Catalona regarding the samples that Dr. Catalona’s patients and participants entrusted to him for his research program while at WU.

To date, WU has not honored the requests of approximately 6,000 men to transfer their tissue and blood samples to Dr. Catalona for his research at Northwestern University.

Earlier this year, eight of Dr. Catalona’s patients and research participants, stating that they own their blood and tissue samples, and federal regulations grant them the right to control the use of them, were added to the litigation as necessary parties.

The matter of ownership and Dr. Catalona’s request for a Permanent Injunction against WU was considered at a formal hearing in April, 2005. A ruling is still to come.

When Dr. Catalona left WU to assume his position at Northwestern University and its comprehensive cancer center, more than 6,000 men signed authorizations that their DNA (both blood and tumor samples) follow Dr. Catalona, so that he could continue his work using their samples. WU has asserted that it owns the samples subject to the participants’ right to withdraw from the studies. If the patients choose to withdraw, WU asserted that it has the sole discretion to either destroy or anonymize the samples.

(“Anonymize” means to strip the samples of the patient identifying information such that they could never again be linked to the individual who provided the samples or to his family.)

If the samples were anonymized, WU could arguably continue to use the samples for any purpose they wish. Such use could include research on matters other than what the participants originally agreed upon in their informed consents. Moreover, anonymization of the samples would forever preclude future research results from ever directly benefiting the patient and his family members.

The patients and Dr. Catalona requested that the samples be transferred to Dr. Catalona as they had asked.

Since the April hearing, two National Institute of Health grants have been funded with Dr. Catalona as a co-investigator, and another is under review, involving research projects for which these samples are needed.

In addition, Dr. Catalona’s research and collaborations with other research institutions could be greatly enhanced by his having control of these samples.

The case remains before the Court for evaluation and decision. QUEST will continue to provide status reports on this issue.